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Completed

NCT Number: NCT02782858

Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS).

This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • For male or female with reproductive potential, use of reliable means of contraception;
  • RRMS according to the 2010 revised McDonald criteria;
  • Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
  • EDSS score < 6.0.

Main Exclusion Criteria:

  • Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
  • Pregnant and nursing women.

Treatment and study plan

GNbAC1

Drug

Monthly IV repeated dose

Placebo

Drug

Monthly IV repeated dose

Primary outcomes

  1. Cumulative number of Gd-enhancing T1 lesions in brain MRI

    Time frame: Week 12 to 24

Sponsors and collaborators

Lead sponsor

GeNeuro SA

Industry

Collaborators

  • Institut de Recherches Internationales Servier
  • Les Laboratoires Servier (LLS)
  • Worldwide Clinical Trials

Registry information

Official study title

An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis

Acronym: CHANGE-MS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 25, 2016
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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